Method and System for Sterilizing an Electrosurgical Instrument

ABSTRACT

An apparatus and method for use in sterilizing a surgical instrument is provided. The apparatus includes a surgical instrument that includes a housing having a shaft extending therefrom. The shaft includes one or more grooves defined therein that extends at least partially along the length thereof. The one or more grooves is configured to allow a sterilant passage therethrough. The apparatus also includes a jacket that encloses the shaft and allows the sterilant to travel along the one or more grooves.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. ProvisionalApplication Ser. No. 61/029,218 entitled “METHOD AND SYSTEM FORSTERILIZING AN ELECTROSURGICAL INSTRUMENT” filed Feb. 15, 2008 by DaleSchmaltz et al, which is incorporated by reference herein.

BACKGROUND

1. Technical Field

The following disclosure relates to an apparatus and method forsterilizing electrosurgical instruments and, more particularly, to anapparatus and method for sterilizing laparoscopic instruments.

2. Description of Related Art

Laparoscopic surgery generally requires deploying a laparoscopicinstrument into a body cavity. Prior to the laparoscopic procedure, thelaparoscopic instrument and components associated therewith must besterilized.

Commonly employed methods of sterilizing laparoscopic instrumentsinclude pasteurization, which requires heating, traditional chemicalmethods, such as chamber methods, which require flooding a chamber witha sterilant, usually a mix of ethylene oxide (commonly referred to EtO)and other gases, and micro-dose methods, which require introducing asterilant, such as EtO, to a specially designed device.

Pasteurization may be an effective method for sterilizing some, but notall, laparoscopic instruments; this is because heat applied duringpasteurization may cause damage to some, if not all, the heat sensitivematerials located on or attached to the laparoscopic instrument.

Traditional chemical methods (e.g., chamber methods) of sterilizationmay have drawbacks inherent to the use of large amounts of sterilantbeing released into a large space, some of which may include increasedcost, increased production time and may require larger amounts of toxicprocessing. Although micro-dose methods alleviate some of the drawbacksassociated with the chamber methods of sterilization, micro-dose methodsof sterilization have drawbacks as well. For example, the micro-dosemethod of sterilization is suitable when a small amount of instrumentsneed to be sterilized.

SUMMARY OF THE DISCLOSURE

Accordingly, the present disclosure is directed to an apparatus for usein sterilizing a surgical instrument. The surgical instrument includes ahousing that has a shaft extending therefrom. The shaft includes one ormore grooves defined therein which extends at least partially the lengththereof. In one embodiment the shaft includes a plurality of groovesextending the entire length thereof disposed in a fixed spatial relationrelative to each other. For example, the plurality of grooves may bedisposed in a generally orthogonal relation to each other. In anembodiment, the plurality of grooves may have a depth of about 0.002″and a width of about 0.004″. The one or more grooves provide a path fora sterilant and is configured to allow a sterilant passage therethroughto infuse and sterilize the housing. In an embodiment the sterilantincludes ethylene oxide.

The apparatus also includes a jacket or coating that encloses the shaft.In an embodiment, the jacket or coating may be in the form of a shrinkwrap that encloses the shaft and allows the sterilant to travel alongthe one or more groves. In an embodiment the shrink wrap is a heatshrink wrap.

The present disclosure is also directed to a method for sterilizing asurgical instrument. The method includes the steps of: providing thesurgical instrument with a shaft. The shaft includes one or more groovesdefined therein which extends at least partially along the lengththereof. The method includes the step of enclosing the shaft with ashrink wrap. The method also includes the step of introducing asterilant into the one or more grooves.

The method may further include the steps of introducing a sterilant intoa sterilization apparatus and subjecting the shrink wrap to a finalshrinking stage, wherein after the final shrinking stage is completedthe shrink wrap forms a tight seal against the shaft.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a perspective view of an endoscopic bipolar forceps shown inopen configuration including a shaft having grooves, a handle assembly,a trigger assembly and an end effector assembly according to anembodiment of the present disclosure;

FIG. 2 is a front view of the forceps of FIG. 1 illustrating the shaftincluding a series of grooves defined thereon according to an embodimentof the present disclosure;

FIG. 3 is a schematic representation of the electrical configuration forthe trigger assembly;

FIG. 4 is a perspective view of different endoscopic bipolar forcepsshown in open configuration including a shaft having grooves, a handleassembly, a trigger assembly and an end effector assembly according toan embodiment of the present disclosure;

FIG. 5A is an enlarged, side view illustrating placement of a groovealong the shaft of the forceps of FIG. 1 according to an embodiment ofthe present disclosure;

FIG. 5B is an enlarged, front view illustrating placement of groovesalong the shaft of the forceps of FIG. 1 according to an embodiment ofthe present disclosure;

FIG. 6A is an enlarged, top view looking into the shafts of the forcepsof FIGS. 1 and 4 illustrating one or more apertures or slits definedthrough the shaft according to an embodiment of the present disclosure;

FIG. 6B is an enlarged, front perspective view of the shafts of theforceps of FIGS. 1 and 4 illustrating a groove extending partially thelength of the shaft including apertures or slits defined through theshaft according to an embodiment of the present disclosure;

FIG. 7 is an enlarged, front perspective view of the shaft of theforceps of FIG. 1 having grooves defined in the shaft according to anembodiment of the present disclosure;

FIG. 8A is an enlarged, cross-sectional view taken along line 8-8 ofFIG. 7 illustrating grooves having a generally arcuate shape;

FIG. 8B is an enlarged, cross-sectional view similar to FIG. 8Aillustrating grooves having a generally square shape;

FIG. 9 is an enlarged, front perspective view illustrating a shrink wrapenclosing the shaft according to an embodiment of the presentdisclosure;

FIG. 10 is an enlarged, front perspective view of another envisionedembodiment having a shaft including tunnels defined therealong forcarrying sterilization gas to the internal operating components of theforceps according to an embodiment of the present disclosure;

FIG. 11 is a flow chart illustrating a method according to an embodimentof the present disclosure; and

FIG. 12 is a flow chart illustrating a second method according to anembodiment of the present disclosure.

DETAILED DESCRIPTION

Detailed embodiments of the present disclosure are disclosed herein;however, the disclosed embodiments are merely exemplary of thedisclosure, which may be embodied in various forms. Therefore, specificstructural and functional details disclosed herein are not to beinterpreted as limiting, but merely as a basis for the claims and as arepresentative basis for teaching one skilled in the art to variouslyemploy the present disclosure in virtually any appropriately detailedstructure.

As mentioned above, laparoscopic instruments, like most surgicalinstruments, require sterilization before they can be introduced to asurgical site. Traditional chamber methods require placing alaparoscopic instrument into a chamber and flooding the chamber with asterilant, which may include a mix of ethylene oxide (hereinafter EtO)and other gases. During the sterilization process the EtO and othergases enter the laparoscopic instrument and sterilize target areasand/or components, for example, those components internally locatedwithin the handle of the laparoscopic instrument (see FIG. 5A). However,due to the fact that the distal end of the shaft, which connects to anend effector of the laparoscopic instrument, may include a gasket, aheat shrink material, adhesive tape, rubber or other insulating boot orsilicone, the sterilant may be impeded from entering the laparoscopicinstrument in a timely fashion. Thus, in order to achieve an effectiveamount of sterilant at a target area more time is required in thesterilization apparatus. The shaft of the present disclosure, because ofthe unique groove and/or tunnel configuration defined therein, providesadditional and/or alternate paths for the sterilant, thus facilitatingthe sterilant in reaching the target area.

The present disclosure relates to sterilizing laparoscopic instruments.As is known in the art, laparoscopic instruments generally include ahandle assembly, a shaft, and an end effector assembly. Conventionally,the shaft is a long narrow generally circumferential tube having anouter and inner surface, which houses mechanical and electricalcomponents that allow the handle and end effector to function asintended. The present disclosure includes a shaft that may include oneor more grooves extending the length thereof (or partially along thelength thereof), to be discussed in greater detail below. The one ormore grooves are configured to provide a path for a sterilant.Additionally, there may be shrink wrap enclosing the shaft, which mayallow the sterilant to travel along the grooves. Having a shaftconfigured in such a manner facilitates in the sterilization process oflaparoscopic instruments.

Because the present disclosure is concerned with sterilizing, and notusing, laparoscopic instruments, an in-depth, detailed description ofthe functioning features of laparoscopic instruments is not vital to theunderstandings of the present disclosure. In order for one skilled inthe art to appreciate the sterilizing apparatus and method, as disclosedherein, only a brief description of two laparoscopic instruments nowfollows.

Turning now to FIG. 1, one embodiment of a laparoscopic instrument 10 isshown. For the remainder of the disclosure it will be assumed that thelaparoscopic instrument is a bipolar forceps; keeping in mind that anylaparoscopic instrument that includes a shaft may be employed with thepresent disclosure. Bipolar forceps 10 is shown for use with variouselectrosurgical procedures and generally includes a housing 20, a handleassembly 30, a rotating assembly 80, a trigger assembly 70 and an endeffector assembly 100 which mutually cooperate to grasp, seal and dividelarge tubular vessels and large vascular tissues. Although the majorityof the figure drawings depict a bipolar forceps 10 for use in connectionwith endoscopic surgical procedures, the present disclosure may be usedfor more traditional open surgical procedures. For the purposes herein,the forceps 10 is described in terms of an endoscopic instrument;however, an open version of the forceps may also include the same orsimilar operating components and features as described below.

Forceps 10 includes a shaft 12, to be described in greater detail below,which has a distal end 16 configured to mechanically engage the endeffector assembly 100 and a proximal end 14 that mechanically engagesthe housing 20. In the drawings and in the descriptions that follow, theterm “proximal,” as is traditional, will refer to the end of the forceps10 that is closer to the user, while the term “distal” will refer to theend that is farther from the user.

As best seen in FIG. 3, forceps 10 also includes an electrosurgicalcable 310 which connects the forceps 10 to a source of electrosurgicalenergy, e.g., a generator 500 (shown schematically). It is contemplatedthat generators such as those sold by Valleylab—a division of TycoHealthcare LP, located in Boulder Colo. may be used as a source ofelectrosurgical energy, e.g., Ligasure™ Generator, FORCE EZ™Electrosurgical Generator, FORCE FX™ Electrosurgical Generator, FORCEIC™, FORCE 2™ Generator, SurgiStat™ II or other suitable generators thatmay perform different or enhanced functions.

Cable 310 is internally divided into cable leads 310 a, 310 b and 325 bwhich are designed to transmit electrical potentials through theirrespective feed paths through the forceps 10 to the end effectorassembly 100. More particularly, cable feed 325 b connects through theforceps housing 20 and through the rotating assembly to jaw member 120.Lead 310 a connects to one side of the switch 60 and lead 310 c connectsto the opposite side of the switch 60 such that upon activation of theswitch energy is transmitted from lead 310 a to 310 c. Lead 310 c isspliced with lead 310 b which connects through the rotating assembly tojaw member 110. Leads 310 a-310 c are but one example of the variousinternal components which need to be sterilized prior to use.

Handle assembly 30 includes a fixed handle 50 and a movable handle 40.Fixed handle 50 is integrally associated with housing 20 and handle 40is movable relative to fixed handle 50. Fixed handle 50 may include oneor more ergonomic enhancing elements to facilitate handling, e.g.,scallops, protuberances, elastomeric material, etc.

Rotating assembly 80 is operatively associated with the housing 20 andis rotatable approximately 180 degrees about a longitudinal axis “A-A”(See FIG. 1).

As mentioned above, end effector assembly 100 is attached at the distalend 14 of shaft 12 and includes a pair of opposing jaw members 110 and120. Movable handle 40 of handle assembly 30 is ultimately connected toa drive assembly 130 which, together, mechanically cooperate to impartmovement of the jaw members 110 and 120 from an open position whereinthe jaw members 110 and 120 are disposed in spaced relation relative toone another, to a clamping or closed position wherein the jaw members110 and 120 cooperate to grasp tissue therebetween.

With reference to FIG. 4, another embodiment of a laparoscopicinstrument 10′ that may be employed with the present disclosure isshown. Laparoscopic instrument 10′ also includes a handle 50′, a shaft12′ and an effector assembly 100′. Shaft 12′ of Forceps 10′ includes aseries of grooves 200′ defined therealong which area configured to carrya sterilant to the various internal operating components thereof.Reference is made to U.S. patent application Ser. Nos. 11/595,194 and11/540,335 for a more detailed explanation of the operation of bothforceps 10 and 10′, respectively.

For the remainder of the disclosure, and for the purposes of brevity,the apparatus and method for sterilizing a laparoscopic instrument willbe described in greater detail with reference to laparoscopic instrument10.

With reference to FIGS. 1, 2, 4, 5A, 5B, and 6A, illustrated in phantomare grooves 200 of shaft 12. The grooves 200 may be molded as part ofshaft 12 during the manufacture process. In an alternate embodiment, atleast one groove 200 may be machined out at a time after the manufactureof shaft 12. 5 Similar to conventional shafts in the art, shaft 12 maybe defined by inner and outer surfaces, 204 and 206, respectively, shownin FIG. 6B. In an embodiment, groove 200 may be located on outsidesurface 206 of shaft 12. Groove 200 of shaft 12 may include one or moreapertures or slits 208 or any combination thereof extending from groove200 to inside surface 204 of shaft 12, as illustrated in FIGS. 7A and7B. Apertures 208 decrease the amount of time it takes for sterilant 210to reach target areas within forceps 10. Apertures or slits 208 may bedisposed anywhere within groove 200 and/or on shaft 12 of laparoscopicinstrument 10. The shape and dimensions of apertures or slits 208 willdepend on the needs of a user.

At least one groove 200 may extend from distal end 16 to proximal end 14of shaft 12, as shown in FIG. 1. Having a groove 200 configured in thismanner will allow sterilant 210 to travel from distal end 16 withingroove 200 to proximal end 14, as shown in FIG. 6A and indicated by thearrow, wherein sterilant 210 may reach a target area, e.g., internalcomponents of housing 20.

In an alternate embodiment, illustrated in FIG. 6B, groove 200 mayextend from distal end 16 of shaft 12 a distance less than the length ofshaft 12 to one or more apertures or slits 208 located within groove 200of shaft 12. Having a shaft configured in this manner may allow thesterilizing agent to travel within groove 200 through aperture 208 intoshaft 12, wherein sterilizing agent 210 may reach a specific targetarea.

With reference to FIGS. 2, 7, 8A-8B shaft 12 may be configured toinclude a plurality of grooves 200. For example, shaft 12 may includefour grooves 200 a-200 d configured to extend the length of shaft 12. Byproviding four (or more) grooves 200 a-200 d more sterilant may travelalong shaft 12 in less time, which may be beneficial for manufacturingpurposes.

The four grooves 200 a-200 d may be disposed in a fixed spaced apartrelation relative to one another on shaft 12. In one embodiment, thefour grooves 200 a-200 d may be spaced apart at approximately 90°intervals, as shown in FIGS. 8A and 8B. It is envisioned that the fourgrooves 200 a-200 d may be disposed in other fixed spaced apartrelations depending upon a particular purpose. For example, grooves 200a and 200 b may be disposed at an angle X relative to each other, whilethe other two grooves 200 c and 200 d may be disposed at an angle Y fromeach other. The manner in which the four grooves 200 a-200 d may bedisposed from each other may be depended on a particular forceps 10.

Grooves 200 a-200 d may have a generally arcuate cross-section, as seenin FIG. 8A or a square shape as illustrated in FIG. 8 b. Other suitableshapes known in the art including but not limited to rectangular,triangular and the like may also be employed with grooves 200 a-200 d ofthe present disclosure. It is envisioned that the grooves 200 may eachhave their own unique shape.

With continued reference to FIGS. 8A and 8B the grooves 200 may have adepth of about 0.002″ and a width of about 0.004″. Other embodiments mayinclude grooves 200 a-200 d with depths greater or less than 0.004″ andwidths greater or less than 0.002″.

Referring now to FIG. 10, a jacket or coating 202 is shown enclosingshaft 12. In an embodiment, jacket 202 may be in the form of a shrinkwrap or other suitable coating that encloses shaft 12 and allowssterilant 210 to travel along grooves 200 a-200 d. Shrink wrap 202 maybe configured to enclose all of shaft 12 or only a portion thereof.

Shrink wrap 202 may be made from any suitable material known in theavailable art including any but not limited to polymer plastic film.Plastic films that can be employed as shrink wrap 202 may includepolyethylene, PVC, and the like. Additionally, shrink wrap 202 may beconfigured for different clarities, shrink ratios, etc. Further, shrinkwrap 202 may be of the kind that shrinks in one direction or multipledirections (e.g., unidirectional or bidirectional shrink wrap,respectively).

During the manufacturing process of bipolar forceps 10, shrink wrap 202may be applied to shaft 12 by any suitable means known in the art. In analternate embodiment, shrink wrap 202 may be applied and partiallyshrunk around shaft 12, the utility of having shrink wrap applied inthis manner will be described in greater detail below.

One type of sterilant that is suitable for use with the presentdisclosure is EtO. As mentioned above, the EtO may be mixed with othergases during the sterilization process. Gases that may be used asdilutants may include but are not limited to CFCs and carbon dioxide.

In normal operation, prior to bipolar forceps 10 being introduced to asurgical site, bipolar forceps 10 must first be sterilized. As mentionedabove, this may be accomplished by at least a couple of methods. For thepurposes of the present disclosure it will be assumed bipolar forceps 10is sterilized via sterilant EtO. As part of the sterilization processbipolar forceps 10 is placed in a sterilization chamber (not shown).Sterilant 210 is then introduced to the sterilization chamber via anysuitable manner. As sterilant 210 is introduced to the sterilizationchamber, sterilant 210 enters laparoscopic instrument 10 where it willreach target areas for sterilizing purposes, that is, the internalcomponents associated with bipolar forceps 10. Having one or moregrooves 200 provides additional paths for sterilant 210 to travel to thetarget area.

From the foregoing and with reference to the various figure drawings,those skilled in the art will appreciate that certain modifications canalso be made to the present disclosure without departing from the scopeof the same. For example, instead of employing one or more grooves 200,shaft 12 may include one or more tunnels 214 defined in shaft 12 or 12′.Tunnel 214 may be configured to function in a similar manner asdescribed above with regard to groove 200. That is, one or more tunnels214 a-214 d may extend the length shaft 12 (or at least partiallythereof), the tunnels 214 a-214 d providing a path for a sterilant 210to reach a target area (see FIG. 10). Tunnel 214 may include aperturesor slits 208 as described above with reference to grooves 200.

The present disclosure also provides a method for sterilizing alaparoscopic instrument the method including the steps of: providing alaparoscopic instrument 10 including: a shaft 12 including one or moregrooves 200 a-200 d extending at least partially the length thereof, thegrooves providing a path for a sterilant; and providing a shrink wrap202 enclosing the shaft and allowing the sterilant to travel along thegrooves. The method also includes the steps of: placing the laparoscopicinstrument into a sterilization apparatus; and introducing the sterilantinto the sterilization apparatus for the purposes of sterilizing thelaparoscopic instrument.

In one embodiment, heat shrink wrap 202 may be subjected to an initialshrinking stage, wherein heat shrink wrap 202 is not completely shrunkprior to placing laparoscopic instrument 10 into a sterilizationapparatus. The sterilization apparatus may be configured to furthershrink the shrink wrap 202. Conventional ways for shrinking heat wrap202 may include a heat tunnel, heat gun, etc., which will not reach atemperature sufficient to cause damage to the internal components of theforceps 10. Thus, after laparoscopic instrument 10 is placed inside thesterilization apparatus and sterilant 210 is introduced, because shrinkwrap 202 is not completely shrunk, sterilant may freely enterlaparoscopic instrument 10 and reach a target area. The method mayfurther include the step of: subjecting the shrink wrap to a finalshrinking stage, wherein after the final shrinking stage is completed,the shrink wrap forms a tight seal against the shaft.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of particular embodiments. Those skilled in the artwill envision other modifications within the scope and spirit of theclaims appended hereto.

1. A surgical instrument, comprising: a housing having a shaft extendingtherefrom; the shaft including at least one groove defined therein thatextends at least partially along the length thereof, the at least onegroove configured to allow a sterilant passage therethrough; and ajacket enclosing the shaft and allowing the sterilant to travel alongthe at least one groove.
 2. The laparoscopic instrument according toclaim 1, wherein the shaft includes a plurality of grooves extending theentire length thereof disposed in a fixed spatial relation relative toeach other.
 3. The laparoscopic instrument according to claim 2, whereinthe plurality of grooves are disposed in a generally orthogonal relationto each other.
 4. The laparoscopic instrument according to claim 1,wherein the plurality of grooves has a depth of about 0.002″ and a widthof about 0.004″.
 5. The laparoscopic instrument according to claim 1,wherein the jacket is a heat shrink wrap.
 6. The laparoscopic instrumentaccording to claim 1, wherein the sterilant includes ethylene oxide. 7.A method for sterilizing a surgical instrument the method comprising thesteps of: providing the surgical instrument with a shaft having at leastone groove defined therein that extends at least partially along thelength thereof; enclosing the shaft with a shrink wrap; and introducinga sterilant into the at least one groove.
 8. The method according toclaim 7, wherein the shaft includes a plurality of grooves extending theentire length thereof disposed in a fixed spatial relation relative toeach other.
 9. The method according to claim 8, wherein the plurality ofgrooves are disposed in a generally orthogonal relation to each other.10. The method according to claim 7, wherein the plurality of grooveshas a depth of about 0.002″ and a width of about 0.004″.
 11. The methodaccording to claim 7, wherein the shrink wrap is a heat shrink wrap. 12.The method according to claim 7, wherein the sterilant includes ethyleneoxide.
 13. A method for sterilizing a laparoscopic surgical instrumentthe method comprising the steps of: providing the surgical instrumentwith a housing having a shaft extending therefrom, the shaft includingat least one groove defined therein that extends at least partially thelength thereof; enclosing the shaft with a shrink wrap; placing thesurgical instrument into a sterilization apparatus; introducing asterilant into the sterilization apparatus for; and subjecting theshrink wrap to a final shrinking stage, wherein after the finalshrinking stage is completed the shrink wrap forms a tight seal againstthe shaft.
 14. The method according to claim 13, wherein thesterilization apparatus is a sterilization chamber.